Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months
| Group | Value (percentage of participants) |
|---|---|
| Carcinoid Tumor | 45.2 |
| Islet Cell Carcinoma | 41.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors.
Experimental
Carcinoid tumor
Participants with carcinoid tumor will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
Experimental
Islet cell carcinoma
Participants with islet cell carcinoma will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
Outcomes the sponsor listed as primary.
Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months
Time frame · From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)
Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.
Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)
Time frame · From Start of Treatment Baseline to Disease Progression (Up to 18 Months)
Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.
Percentage of Participants With a Biochemical Response Rate
Time frame · From Start of Treatment Up to 18 Months
Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Time frame · 18 months
Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1
Time frame · Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Half-life (t 1/2) Cycle 1
Time frame · Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Area Under Concentration (AUCinf) Cycle 1
Time frame · Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Clearance (CL) Cycle 1
Time frame · Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Volume at Steady State (Vss) Cycle 1
Time frame · Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Serum Anti-Cixutumumab Antibody Assessment
Time frame · 18 months
Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2
Time frame · 18 months
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Carcinoid Tumor | 45.2 |
| Islet Cell Carcinoma | 41.7 |
| Group | Value (percentage of participants) |
|---|---|
| Carcinoid Tumor | 3.2 |
| Islet Cell Carcinoma | 0 |
| Group | Value (percentage of participants) |
|---|---|
| Carcinoid Tumor | 0.0 |
| Islet Cell Carcinoma | 22.2 |
| Group | Value (Participants) |
|---|---|
| Carcinoid Tumor | 31 |
| Islet Cell Carcinoma | 12 |
| Group | Value |
|---|---|
| Carcinoid Tumor | not posted |
| Islet Cell Carcinoma | not posted |
| Group | Value |
|---|---|
| Carcinoid Tumor | not posted |
| Islet Cell Carcinoma | not posted |
| Group | Value |
|---|---|
| Carcinoid Tumor | not posted |
| Islet Cell Carcinoma | not posted |
| Group | Value |
|---|---|
| Carcinoid Tumor | not posted |
| Islet Cell Carcinoma | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Carcinoid TumorParticipants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen. | – | 12 / 31 | 31 / 31 |
| Islet Cell CarcinomaParticipants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen. | – | 6 / 12 | 12 / 12 |
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